OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR 26 FR. OUTER SHEATH; RESECTION SHEATHS, IRRIGATION RINGS, CYSTOSCOPE SHEATHS, HYSTEROSCOPE SHEATHS
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Model Number A22040A |
Device Problems
Break (1069); Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility refused to return the suspect medical device to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed as basic data of article identification (lot number) are missing.The case will be closed from olympus side with no further actions but may be reopened if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.In addition, the event/incident will be recorded for trending and surveillance purposes.
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Event Description
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Olympus was informed that during an unspecified hysteroscopic procedure, the ceramic insulation at the distal end of the resection sheath broke off and fell inside the patient.However, no fragment remained inside the patient since the ceramic insulation was successfully retrieved.No further information was provided but the intended procedure had to be interrupted and there was no report about an adverse event or patient injury.
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Event Description
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The intended procedure was successfully completed with another similar device and there was no report about an adverse event or patient injury.
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Search Alerts/Recalls
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